510(k) K072612 ยท MOI System, Test, Immunological, Antigen, Tumor
ACCESS IMMUNOASSAY SYSTEMS BR MONITOR, AND CALIBRATORS, MODEL(S) 387620,AND 387647
| Applicant | Beckman Coulter, Inc., Chaska MN, US |
| Decision | Substantially Equivalent, Oct 26, 2007 |
| Received | Sep 17, 2007 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K072612
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 13, 2017 | Beckman Coulter Inc. Access BR Monitor, Part No. 387620 Terminated |
MOI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.